
Veristat
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• Support the Medical Affairs department leadership in the development and implementation of medical and operational strategies, policies, and procedures • Manage and participate in the medically related activities within the planning and execution of clinical trials • Assist in the study feasibility process and be actively involved in all activities related to patient safety and pharmacovigilance, medical monitoring, medical training, and business development • Provide day-to-day leadership and manage direct reports within the Medical Affairs Department • Accountable for multiple projects and clients, managing client relationships and business expectations, delivering results successfully • Maintain a proactive, positive, result-oriented work environment
Role Description The Principal Medical Writer independently plans and prepares a range of regulatory documents and medical communications to support all phases of product development. The primary responsibilities of the position are: - Organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with International Council for Harmonisation (ICH) and other regulatory guidelines. - Collaborating with cross-functional internal and external document production teams. Qualifications - Bachelor’s degree required; science-related field preferred. - Minimum of 7 years of medical writing experience in a contract research organization or pharmaceutical/biotechnology research setting. Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case-by-case basis. - Advanced knowledge of ICH and related regulatory guidelines. - Excellent written English and keen attention to detail. - Strong interpersonal and communication skills. - Experience with Microsoft Office Suite is essential, including advanced Microsoft Word proficiency. Benefits - Remote working - Flexible time off - Paid holidays - Medical insurance - Tuition reimbursement - Retirement plans Company Description Make an Impact at Veristat! Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide. - 105+ approved therapies for marketing applications prepared by Veristat - 480+ oncology projects in the past 5 years - 350+ rare disease projects delivered in the past 5 years - Flexible, inclusive culture — 70% remote workforce, 66% women-led teams
Role Description Under the direction of management or an experienced Proposals lead, the Proposals & Contracts (“P&C”) Specialist is responsible for the development of proposals and contracts for new and existing business, in consultation with the Sales Team. S/he gathers and provides increasingly complex information for proposals with oversight from P&C lead. The P&C Specialist may begin to lead proposals of minimal complexity. Make an Impact at Veristat! - Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide. - 105+ approved therapies for marketing applications prepared by Veristat. - 480+ oncology projects in the past 5 years. - 350+ rare disease projects delivered in the past 5 years. - Flexible, inclusive culture — 70% remote workforce, 66% women-led teams. Qualifications - 2 years of Proposal/Contract experience in the clinical research industry, preferably with a Contract Research Organization (CRO), required. - Understanding of the functional relationship between CROs and Sponsors required. - Excellent interpersonal, communication and time management skills required, including strong detail orientation. - Ability to work creatively and multi-task in a fast-paced environment required. - Ability to learn quickly and assimilate the detail of project requirements required. - Comprehensive knowledge of relevant software (Word, Excel, Outlook) required, and proficient experience with Salesforce required. Requirements - Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process. Benefits - The estimated hiring range for this role is $67K-80K plus applicable bonus. This hiring range is specific to the USA and will vary for other regions based upon local market data. - Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data. - Benefits vary by location and may include: - Remote working - Flexible time off - Paid holidays - Medical insurance - Tuition reimbursement - Retirement plans Company Description Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Role Description The Human Resources Operations Manager is responsible for providing general Human Resources support, guidance, and subject matter expertise to the Company, primarily around matters of employment events such as hires, changes, and departures. They are responsible for ensuring that employees and managers have appropriate support and resources from the department and external partners. Qualifications - Bachelor’s Degree required - 5-8 years of experience in Human Resources required - Prior experience and knowledge of payroll and HRIS systems required; WorkDay and ADP preferred - Strong Microsoft Office skills (specifically Outlook, Excel, and PowerPoint) - Excellent organizational skills, strong attention to detail, ability to juggle multiple and often competing priorities with professionalism - Demonstrated ability to manage ambiguous or evolving circumstances, maintain highly confidential information, and navigate complex employee issues - Strong communication skills (written and verbal), ability to effectively partner with internal and external customers, and strong consultation skills - Ability to influence without authority, think critically, and effectively problem solve in unclear or difficult situations Requirements - Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process. Benefits - Remote working - Flexible time off - Paid holidays - Medical insurance - Tuition reimbursement - Retirement plans Company Description Make an Impact at Veristat! Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide. - 105+ approved therapies for marketing applications prepared by Veristat - 480+ oncology projects in the past 5 years - 350+ rare disease projects delivered in the past 5 years - Flexible, inclusive culture — 70% remote workforce, 66% women-led teams
• Independently plans and prepares a range of regulatory documents and/or medical communications to support all phases of product development. • Organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with industry guidelines.
• The Principal Medical Writer independently plans and prepares a range of regulatory documents and medical communications to support all phases of product development. • Organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with International Council for Harmonization (ICH) and other regulatory guidelines, and individual company document standards. • Work closely with client and internal and partner organization teams to lead development of strategies for organizing and preparing regulatory documents. • Lead a project team, and actively participate in development and writing of high-quality documents (study-level and submission level documents, pharmacovigilance documents). • Author documents per client specifications, templates, style guides, and other guidance documents. • Author documents per regulatory authority guidelines and requirements. • Act as client advisor, working collaboratively and developing a strong relationship of trust built upon consistent and reliable communication; communicate ideas and strategies to produce a successful end result. • Practice blameless problem solving, taking broad perspectives in resolving issues to prevent negative impact to work. • Manage budget for a low complexity project, including all contributors (writers, editors). • Usher documents through the review process, conduct comment resolutions meetings (CRMs) and successfully lead a project team to consensus. • Maintain collaborative, proactive, and effective communication with both clients and internal teams. • Lead project-related meetings and teleconferences. • Provide coaching to junior staff for study level documents as well as submission level documents and ensure all staff comply with company standard operating procedures (SOPs) and training requirements.
Role Description Under the direction of management or an experienced Proposals lead, the Senior Proposals & Contracts (“P&C”) Specialist is responsible for the development of proposals and contracts for new and existing business, in consultation with the Sales Team. S/he gathers and provides increasingly complex information for proposals with oversight from P&C lead. The Senior P&C Specialist will lead proposals of increasing complexity with assistance as needed. Qualifications - Bachelor’s Degree in a related field (Science, Business, Clinical Research) required. - 5 – 7 years of Proposal/Contract experience in the clinical research industry, preferably with a Contract Research Organization (CRO), required. - Understanding of the functional relationship between CROs and Sponsors required. - Excellent interpersonal, communication and time management skills required, including strong detail orientation. - Ability to work creatively and multi-task in a fast-paced environment required. - Ability to learn quickly and assimilate the detail of project requirements required. - Comprehensive knowledge of relevant software (Word, Excel, Outlook) required, and proficient experience with Salesforce required. Requirements - Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process. Benefits - Flexible, inclusive culture — 70% remote workforce, 66% women-led teams.
• Responsible for the development and expansion of new business opportunities within established accounts and prospective clients. • Provides leadership for overall business planning. • Identifies and develops sales leads, managing the sales process through contract closure. • Prepares and conducts project-specific client presentations. • Liaises between the client and Company on all sales activities and requirements. • Assists with the development of promotional material for Company recognition. • Works closely with Project Management and Finance to establish strategic partnerships with clients.
• Major contributor to document authorship for a variety of documents across different service lines • Project lead on smaller projects, interfacing directly with the client • Support larger, more complex engagements as a member of a larger delivery team • Use expertise in clinical regulatory writing to lead teams and help clients achieve their goals
• Ensure compliance with relevant guidelines and regulations in a GxP environment • Responsible for Document Management in the eDMS MasterControl • Collaborate with line manager and QA team
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